Tag: pubmed

Braz J Cardiovasc Surg. 2021 Jul 7. doi: 10.21470/1678-9741-2020-0618. Online ahead of print.

ABSTRACT

INTRODUCTION: Coronary artery ectasia (CAE) is one of the uncommon cardiovascular disorders and its prognosis is still debated.

OBJECTIVE: We aimed to review long-term follow-up data in patients with CAE and to evaluate the prognosis of CAE patients with coronary slow flow phenomenon (CSFP).

METHODS: This study had a prospective design and 143 patients with CAE were included. The angiographic and demographic characteristics were reviewed in detail. The patients were categorized, based on concomitant coronary artery stenosis detected by angiography, as CCAE group (n=87, ≥30% luminal stenosis) and ICAE group (n=56, <30% luminal stenosis) and also categorized by the coronary flow as CSFP group (n=51) and normal flow coronary ectasia – NCEA group (n=92). All patients were re-evaluated at 6-month intervals. Followup data, cardiovascular (CV) mortality, hospitalization and major adverse cardiac events (MACE) were collected. The level of statistical significance was set at 5%.

RESULTS: Patients were followed up for an average of 56.9±7.4 months. During the follow-up, statistically significant differences were found in hospitalization, CV mortality and MACE between the CCAE and ICAE groups (P=0.038, P=0.003, P=0.001, respectively). The CSFP and NCEA groups were also compared. There was a statistical difference with respect to hospitalization between the CFSP and NCEA groups (P=0.001), but no difference was observed in terms of MACE and CV mortality (P=0.793 and P=0.279).

CONCLUSION: CSFP accompanying CAE may be a predictor of hospitalization. Significant atherosclerotic plaques coexisting with CAE may be predictive for MACE.

PMID:34236824 | DOI:10.21470/1678-9741-2020-0618

Cancer Rep (Hoboken). 2021 Jul 8:e1490. doi: 10.1002/cnr2.1490. Online ahead of print.

ABSTRACT

BACKGROUND: There is strong evidence supporting the efficacy of exercise oncology programs to improve physical and psychosocial outcomes during active treatment. However, there is a paucity of evidence on the effect of exercise on healthcare utilization and cost analyzes of exercise oncology programs.

AIMS: Our objective was to assess the effects of a pragmatic exercise oncology program (ENACT) during active chemotherapy treatment on healthcare utilization and associated costs.

METHODS: We conducted post-hoc analyzes on 160 ENACT participants and 75 comparison participants matched on cancer site, stage, age range, and gender. We obtained complete healthcare utilization histories for each patient (specific to emergency department [ED] visits and hospital admissions) coinciding with their participation in ENACT. A sub-analysis was conducted for advanced stage breast, gastrointestinal, and pancreatic cancer patients.

RESULTS: Healthcare costs for patients who participated in the ENACT exercise oncology intervention were numerically lower than healthcare costs for the comparison group, even after accounting for the cost of the intervention. However, the differences were not statistically significant.

CONCLUSION: Our findings suggest that an exercise oncology program during active chemotherapy treatment are at least cost neutral for all cancer patients, including advanced stage cancers. Additional research is warranted to evaluate the potential for exercise oncology programs to reduce healthcare utilization, particularly in advanced cancer patients.

PMID:34236137 | DOI:10.1002/cnr2.1490

Hemodial Int. 2021 Jul 8. doi: 10.1111/hdi.12971. Online ahead of print.

ABSTRACT

INTRODUCTION: Intradialytic hypotension (IDH) is a common complication of hemodialysis (HD) and is associated with excess morbidity and mortality. Higher serum phosphate is associated with adverse cardiovascular outcomes in maintenance HD patients; however, its association with IDH has not previously been assessed.

METHODS: This is an analysis of a prospective cohort of 969 HD patients (80,968 HD sessions) receiving HD at a large dialysis organization (LDO) and a post-hoc analysis of 1838 HD patients (10,594 HD sessions) in the Hemodialysis study (HEMO), a multicenter randomized controlled trial that examined standard or high-dose HD and low-flux or high-flux membranes. Unadjusted and adjusted mixed effects regression models were fit to determine the association of pre-HD serum phosphate with IDH, defined as a nadir intra-HD systolic blood pressure (SBP) <90 mmHg.

FINDINGS: In the LDO cohort, baseline mean pre-HD serum phosphate was 5.2 ± 1.7 mg/dl. IDH occurred in 15.6% of HD sessions. In the adjusted model, higher pre-HD serum phosphate (per 1 mg/dl) was associated with a 12% increased risk of IDH (aOR 1.12, 95% CI 1.10-1.13, p <0.001). In exploratory models where pre-HD laboratory values were available, the effect estimate was attenuated but remained statistically significant (aOR 1.05; 95% CI 1.02-1.08; p <0.01). Participants in the highest (compared with the lowest) quartile of pre-HD serum phosphate had a 56% greater risk of IDH in the adjusted model (aOR Q4:Q1 1.56; 95% CI 1.44-1.68, p <0.001). The association of higher phosphate with IDH was consistent in the HEMO data.

DISCUSSION: Higher pre-HD serum phosphate is independently associated with an increased risk of IDH. As HD may cause an acute decline in serum phosphate, future studies to investigate the mechanisms of this association are warranted.

PMID:34236130 | DOI:10.1111/hdi.12971

Int J Clin Pract. 2021 Jul 8:e14497. doi: 10.1111/ijcp.14497. Online ahead of print.

ABSTRACT

INTRODUCTION: The present study aimed to investigate the contribution of cone-beam computed tomography (CBCT) to the diagnosis of obstructive sleep apnoea syndrome (OSAS).

METHODS: The present study investigate the relationships among body mass index (BMI), upper airway, septum deviation, nasal cavity width, airway, and the hard and soft palate width using CBCT images of 64 patients obtained in Uşak University Faculty of Dentistry. The study included 31 (8 female and 23 male; mean age: 52.52 ± 10.01 years) and 33 patients (12 female and 21 male; mean age: 47.39 ± 10.27 years) with and without OSAS, respectively. Between-group comparisons of non-normally and normally distributed variables were performed using the Mann-Whitney U test and Student’s t-test, respectively. Spearman’s correlation analysis was used to determine the relationship between quantitative data. Statistical significance was evaluated at P < .01 and P < .05.

RESULTS: There were significant differences between groups in the BMI, nasal septum position, hard and soft palate width, maxillary skeletal width, and palatal alveolar angle (P < .01). In addition it was also found that BMI was higher, the nasopharyngeal airway was longer, and the soft palate was longer and wider in males. (P = .001; P < .01).

CONCLUSION: This study concluded that patients with OSAS had marked narrowing of the upper airway, nasal cavity and maxillary width, shortening and enlargement of the soft palate, and marked increase in BMI. However, to gather sufficiently reliable data for routine use in orthodontic analyses, there is a need for greater number of samples to improve the database.

PMID:34236117 | DOI:10.1111/ijcp.14497

J Magn Reson Imaging. 2021 Jul 8. doi: 10.1002/jmri.27824. Online ahead of print.

ABSTRACT

BACKGROUND: The Liver Imaging Reporting and Data System (LI-RADS) is widely accepted as a reliable diagnostic scheme for hepatocellular carcinoma (HCC) in at-risk patients. However, its application is hampered by substantial complexity and suboptimal diagnostic sensitivity.

PURPOSE: To propose data-driven modifications to the LI-RADS version 2018 (v2018) major feature system (rLI-RADS) on gadoxetate disodium (EOB)-enhanced magnetic resonance imaging (MRI) to improve sensitivity and simplicity while maintaining high positive predictive value (PPV) for detecting HCC.

STUDY TYPE: Retrospective.

POPULATION: Two hundred and twenty-four consecutive at-risk patients (training dataset: 169, independent testing dataset: 55) with 742 LR-3 to LR-5 liver observations (HCC: N = 498 [67%]) were analyzed from a prospective observational registry collected between July 2015 and September 2018.

FIELD STRENGTH/SEQUENCE: 3.0 T/T2-weighted fast spin-echo, diffusion-weighted spin-echo based echo-planar and three-dimensional (3D) T1-weighted gradient echo sequences.

ASSESSMENT: All images were evaluated by three independent abdominal radiologists who were blinded to all clinical, pathological, and follow-up information. Composite reference standards of either histopathology or imaging follow-up were used.

STATISTICAL TESTS: In the training dataset, LI-RADS v2018 major features were used to develop rLI-RADS based on their associated PPV for HCC. In an independent testing set, diagnostic performances of LI-RADS v2018 and rLI-RADS were computed using a generalized estimating equation model and compared with McNemar’s test. A P value <0.05 was considered statistically significant.

RESULTS: The median (interquartile range) size of liver observations was 13 mm (7-27 mm). The diagnostic table for rLI-RADS encompassed 9 cells, as opposed to 16 cells for LI-RADS v2018. In the testing set, compared to LI-RADS v2018, rLI-RADS category 5 demonstrated a significantly superior sensitivity (76% vs. 61%) while maintaining comparably high PPV (92.5% vs. 94.1%, P = 0.126).

DATA CONCLUSION: Compared with LI-RADS v2018, rLI-RADS demonstrated improved simplicity and significantly superior diagnostic sensitivity for HCC in at-risk patients.

LEVEL OF EVIDENCE: 3 TECHNICAL EFFICACY STAGE: 2.

PMID:34236120 | DOI:10.1002/jmri.27824

Environ Toxicol Chem. 2021 Jul 8. doi: 10.1002/etc.5152. Online ahead of print.

ABSTRACT

Deriving water quality criteria (WQC) for aquatic risk assessment, requires sufficient toxicity data, which can determine the accuracy of WQC. Given that toxicity data varies between test species and endpoints, there is a great need to compare such data to generate the most suitable data set for WQC derivation. In this study, a series of 11 ammonia exposure bioassays were conducted on Chironomidae species in either China or Australia, with test species and test endpoints varied (2 Chironomus sp., enzymatic up to lethal endpoints, and NOEC up to LC50 as endpoint metrics). It was found that there were no statistically significant differences between toxicity results generated from China compared to Australia using Chironomus sp., indicating that published data on native species generated in different countries could be appropriate for inclusion in the development of local Chinese WQC. In addition, Chironomidae larvae laboratory-based toxicity value (LC50 of 384.6 mg/L) was lower than that of the in situ field-based toxicity value (LC50 ≥ 451.2 mg/L) where sensitive life stages are used and, specifically for C. riparius, endpoints linked to biochemical and gene expression effects could be as sensitive, or more sensitive than chronic endpoints, both of which were more sensitive than acute endpoints. These findings help in the development of WQC by demonstrating the suitability of inclusion of toxicity data from a range of sources, as well as adding to the overall pool of knowledge regarding sensitivity to ammonia which can be used in aquatic risk assessment. This article is protected by copyright. All rights reserved.

PMID:34236106 | DOI:10.1002/etc.5152

Environ Toxicol Chem. 2021 Jul 8. doi: 10.1002/etc.5154. Online ahead of print.

ABSTRACT

Bumblebees can be exposed to neonicotinoid pesticides through nectar and pollen collected from treated crops, which can cause lethal and sublethal effects in these non-target pollinators. However, the body distribution of the compound after exposure to neonicotinoids in bumblebees is not well studied. Bumblebee colonies (Bombus terrestris, n = 20) were exposed to field-realistic concentrations of clothianidin through artificial nectar (3.6 µg/L – 13 µg/L) for nine days. Comparison of the nominal- to the measured exposure in nectar indicated good compliance, confirming the applicability of the method. When quantified, clothianidin showed a concentration-dependent occurrence in the head and body of workers (head: <0.2 – 2.17 µg/kg, body: <0.2 – 3.17 µg/kg), and in the body of queens (<0.2 – 2.49 µg/kg), although concentrations were below that measured in the nectar (Bioaccumulation factor = 0.2). Exposure to clothianidin did not affect mortality nor brood production, nor have a statistically significant effect on nectar consumption and size of food storage. However, visual inspection suggests higher nectar consumption of nectar with low clothianidin content compared to nectar with no or high clothianidin content. Our results show that dietary clothianidin is taken up in bumblebees, but does not bioaccumulate to elevated levels compared to exposure. Still, clothianidin may elicit responses that affect feeding behaviour of the pollinator B. terrestris, although our endpoints were not significantly affected. This article is protected by copyright. All rights reserved.

PMID:34236107 | DOI:10.1002/etc.5154

Laryngoscope. 2021 Jul 8. doi: 10.1002/lary.29746. Online ahead of print.

ABSTRACT

OBJECTIVES/HYPOTHESIS: Dermal filler (DF) is a widely used nonsurgical option for facial rejuvenation with a rapidly expanding market. Physician payments by DF industry leaders have yet to be characterized. We sought to investigate trends in physician-industry payments by DF companies over 6 years. Differences in payments based on physician specialty and time were characterized.

STUDY DESIGN: Database review.

METHODS: The Open Payments Database was queried from 2013 to 2018. Payments made by the three largest DF companies by market share to otolaryngologists, plastic surgeons, and dermatologists were analyzed. Total dollars paid, number of payments made, type of payments made, and total number of specialists paid were recorded. One-way ANOVA was used for statistical analysis.

RESULTS: Otolaryngologists, plastic surgeons, and dermatologists received average annual payments of $0.36 million, $6.3 million, and $6.6 million respectively (P < .001). An average of 330 otolaryngologists, 2,128 plastic surgeons, and 5,980 dermatologists were paid annually (P < .001). Accredited speaking arrangements, consulting fees, and royalty/licensing fees comprised the majority of dollars paid to physicians.

CONCLUSIONS: Average physician payment by DF companies exceeds $12 million annually, with otolaryngologists receiving significantly less compared to plastic surgeons and dermatologists.

LEVEL OF EVIDENCE: Not applicable Laryngoscope, 2021.

PMID:34236083 | DOI:10.1002/lary.29746

Mov Disord. 2021 Jul 8. doi: 10.1002/mds.28703. Online ahead of print.

ABSTRACT

BACKGROUND: There are limited data regarding the effectiveness of levodopa-carbidopa intestinal gel (LCIG) for dyskinesia.

OBJECTIVE: Compare the effectiveness of LCIG versus oral optimized medical treatment (OMT) for dyskinesia in patients with advanced Parkinson’s disease (PD) using the Unified Dyskinesia Rating Scale (UDysRS).

METHODS: This phase 3b, open-label, multicenter, 12-week, interventional study (NCT02799381) randomized 63 LCIG naïve patients with advanced PD (UDysRS ≥30) to LCIG (N = 30) or OMT (N = 33) treatment. Dyskinesia impact was assessed at baseline through week 12 using the UDysRS. PD-related motor and non-motor symptoms, and quality of life (QoL) were also assessed.

RESULTS: Dyskinesias measured by UDysRS were significantly reduced in the LCIG group (n = 24; -17.37 ± 2.79) compared with the OMT group (n = 26; -2.33 ± 2.56) after 12 weeks (-15.05 ± 3.20; 95% CI, -21.47 to -8.63; P < 0.0001). At week 12, LCIG versus OMT also demonstrated significant improvements in “On” time without troublesome dyskinesia (P = 0.0001), QoL (P < 0.0001), global impression of change (P < 0.0001), activities of daily living (P = 0.0006), and Unified Parkinson’s Disease Rating Scale (UPDRS) Part III (P = 0.0762). Treatment-emergent adverse events were reported in 27 (44.3%) patients (LCIG, 18 [64.3%]; OMT, 9 [27.3%]). Serious adverse events occurred in 2 (7.1%) LCIG-treated patients.

CONCLUSIONS: LCIG significantly reduced dyskinesia compared with OMT. LCIG showed efficacy for treatment of troublesome dyskinesia in patients with advanced PD while demonstrating benefits in both motor and non-motor symptoms and QoL. © 2021 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.

PMID:34236101 | DOI:10.1002/mds.28703

Curr Med Res Opin. 2021 Jul 8:1. doi: 10.1080/03007995.2021.1947216. Online ahead of print.

ABSTRACT

OBJECTIVE: Onasemnogene abeparvovec, a one-time intravenous gene replacement therapy, and nusinersen, an antisense oligonucleotide that requires ongoing intrathecal administration, have been evaluated as treatments for spinal muscular atrophy (SMA) type 1 in separate Phase III trials, but no head-to-head comparison studies have been conducted. Onasemnogene abeparvovec was compared with nusinersen using a matching-adjusted indirect comparison (MAIC) to estimate the treatment effect of onasemnogene abeparvovec relative to nusinersen for the treatment of symptomatic patients with SMA type 1 for up to 24 months of follow-up.

METHODS: In the absence of studies for both onasemnogene abeparvovec and nusinersen with a common comparator, a Bayesian naïve indirect treatment comparison (ITC) and MAIC between onasemnogene abeparvovec and nusinersen were conducted to compare efficacy and safety of onasemnogene abeparvovec with nusinersen. Outcomes of interest were event-free survival (EFS), overall survival (OS), and motor milestone achievements (independent sitting and independent walking). Relative treatment effects were expressed as relative risk (RR) and risk difference.

RESULTS: Pooled and weighted patient-level data illustrated a favorable effect toward onasemnogene abeparvovec, suggesting longer EFS for patients compared with nusinersen (HR of onasemnogene abeparvovec vs. nusinersen: 0.19 [95% CI: 0.07-0.54; 99% CI: 0.05-0.74]). At 24 months of follow-up, patients receiving onasemnogene abeparvovec were statistically significantly more likely to achieve the motor milestone of sitting independently compared with patients treated with nusinersen. Although statistically significant differences were not observed at 6 to 18 months between treatment options, the likelihood of sitting independently at 12 and 18 months numerically favored onasemnogene abeparvovec. A numerically greater likelihood of walking by 18 and 24 months was also observed for patients treated with onasemnogene abeparvovec compared with nusinersen. Onasemnogene abeparvovec therapy was also associated with a favorable (but statistically nonsignificant) outcome for OS and may be associated with prolonged survival compared with nusinersen (HR of onasemnogene abeparvovec vs. nusinersen: 0.35 [95% CI: 0.09-1.32; 99% CI: 0.06-2.01]). Bayesian naïve ITC results were similar to the MAIC analysis for EFS, OS, and motor milestone achievements. Small sample size limited covariate matching to baseline CHOP INTEND and nutritional support requirement, leading to wider CIs and statistically inconclusive outcomes for some of the results.

CONCLUSIONS: Despite limitations of the current MAIC analysis (mainly a small sample size for statistical testing, even for the pooled onasemnogene abeparvovec trials, and potential differences in prognostic and predictive factors between studies), the relative treatment effects in EFS, OS, and motor milestone achievement indicate that onasemnogene abeparvovec may offer continued benefit compared with nusinersen through 24 months of follow-up.

PMID:34236007 | DOI:10.1080/03007995.2021.1947216